An observational study in Myopia and Small-incision Lenticule Extraction (SMILE) Surgery, sponsored by Yifeng Yu. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by Yifeng Yu · Observational
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.
Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.
1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 3,003 is above the median of 150 across 176 observational studies indexed under Myopia.
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Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University
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Exclusion Criteria:
Eyes with SMILE surgeries which were performed by three surgeons with different experiences.
Procedure: Small incision lenticule extraction
Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).
The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.
Time frame: Day 0
The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
The spherical equivalent of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of spherical equivalent on the UIDPP in SMILE surgeries.
Time frame: Day 0
The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
The peripheral corneal incision angle of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
Time frame: Day 0
The impact of peripheral lens thickness on the unintended initial dissection
The peripheral lens thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
Time frame: Day 0
The impact of lens diameter on the unintended initial dissection
The lens diameter of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of lens diameter on the UIDPP in SMILE surgeries.
Time frame: Day 0
The impact of central corneal thickness on the unintended initial dissection
The central corneal thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of central corneal thickness on the UIDPP in SMILE surgeries.
Time frame: Day 0
Plan to share: No
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Yifeng Yu